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  1. Legal news
    22 November 2019
    Access to toxicity study reports and protection of commercial interests
    www.twobirds.com/en/news/articles/2019/uk/access-to-toxicity-study-reports-and-protection-of-commercial-interests

    Gerard Hogan, Advocate General at the Court of Justice of the European Union (“CJEU”) recently delivered an opinion in the pending case between MSD Animal Health Innovation (“MSD”), Intervet international (“Intervet”) ...

  2. Legal news
    19 November 2019
    The English Patents Court examines the law on enablement in the context of lack of novelty based on both prior publication and prior use.
    www.twobirds.com/en/news/articles/2019/uk/the-english-patents-court-examines-the-law-on-enablement-in-the-context-of-lack

    Earlier this year (17 July 2019) in Takeda UK Limited v F. Hoffmann-La Roche AG Mr Justice Colin Birss of the Patents Court of the English High Court of Justice handed down a judgment holding that Roche’s European ...

  3. Legal news
    16 May 2019
    Report from Med-Tech Innovation Expo 2019
    www.twobirds.com/en/news/articles/2019/uk/bird-and-birds-ewan-grist-chris-de-mauny-and-toby-bond-spoke-at-the-med-tech-innovation-expo

    Ewan explored the legal issues which arise at various stages of the lifecycle of a medical device; from product concept, though prototyping, testing, refinement, manufacture, marketing and placing on the market.

  4. Legal news
    04 June 2019
    Investing in the future of cannabis in the UK - lessons from the German model
    www.twobirds.com/en/news/articles/2019/uk/investing-in-the-future-of-cannabis-in-the-uk--lessons-from-the-german-model

    The excitement around the potential for the UK cannabis market – medicinal and nutritional – to continue opening up has really intensified in the first half of 2019.

  5. Legal news
    11 December 2018
    The legal basis for Belgian biobanks enters into force
    www.twobirds.com/en/news/articles/2018/belgium/the-legal-basis-for-belgian-biobanks-finally-enters-into-force

    Each Belgian biobank will have to be declared at the Federal Agency for Medicines and Health Products (FAMHP) in order to operate. It also imposes binding content for agreements on the transfer of human biological ...

  6. Legal news
    11 December 2018
    Changes afoot for Belgian manufacturers of allogeneic ATMPs
    www.twobirds.com/en/news/articles/2018/belgium/changes-afoot-for-belgian-manufacturers-of-allogeneic-atmps

    Last month, the Belgian Parliament voted in favour of a set of measures that are notably meant to clarify the regulatory landscape of the operators active in the manufacturing of Advanced Therapy Medicinal Products ...

  7. Legal news
    11 December 2018
    Pemetrexed: Italian Court reversed the first instance decision ordering a PI on the basis of Eli Lilly's patent
    www.twobirds.com/en/news/articles/2018/italy/italian-court-reversed-the-first-instance-decision-ordering-a-pi-on-the-basis-of-eli-lillys-patent

    Diverging from the previous decision, the Court pointed out that the relevance of the file history to construe the scope of protection of a patent and then the infringement of equivalence has to be carefully and ...

  8. Legal news
    15 November 2018
    Supreme Court defines plausibility in the context of sufficiency
    www.twobirds.com/en/news/articles/2018/uk/supreme-court-defines-plausibility-in-the-context-of-sufficiency

    A majority postulates a new "outward presentation test" to deal with the infringement of second medical use patents.

  9. Legal news
    24 July 2020
    China Updates Drug Registration Rules and the Measures for Monitoring Drug Production – Part 1
    www.twobirds.com/en/news/articles/2020/china/china-updates-drug-registration-rules-and-the-measures-for-monitoring-drug-production

    Overall, the new DRR and AMMDP provide further clarity to the provisions of the new DAL. The obvious step toward improving the review and approval process, and the reduction in the need for onsite review for many ...